THAM vs. sodium bicarbonate for metabolic acidosis after cardiac surgery
Official title: THAM VErsus Sodium BiCarbOnate In CaRdiac SuRgical PatiEnts, A PragmatiC, Comparative-effectiveness Prospective Trial
Run by Mayo Clinic · NCT07424625 · Data updated 2026-11-12
This trial tests whether THAM and sodium bicarbonate perform similarly to correct metabolic acidosis in patients having heart surgery with bypass.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 21 Years and up |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Status | Recruiting |
| Started | September 14, 2026 |
| Main results expected | December 2027 |
| Study ends | June 2028 |
| Registry record updated | September 21, 2026 |
| Trial ID | NCT07424625 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults undergoing cardiothoracic surgery with cardiopulmonary bypass who develop metabolic acidosis (base excess < -5) and have Minnesota Research Authorization.
✕Probably not a fit
Patients without metabolic acidosis or those not on cardiopulmonary bypass may not benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional Phase 4 study compares two treatments for metabolic acidosis occurring during cardiac surgery with cardiopulmonary bypass. Participants are adults undergoing cardiothoracic surgery who develop metabolic acidosis, defined by a base excess below -5, and have Minnesota Research Authorization. The study aims to determine if THAM is equivalent to sodium bicarbonate in addressing the metabolic disturbance. Mayo Clinic leads the trial at its Rochester, Minnesota site with no listed collaborators. Eligible participants are identified within the Mayo Clinic patient population and are recruited under applicable authorization and consent processes.
Why it matters
Potential benefit: If equivalent, either treatment could be used in this setting, potentially guiding safer or more convenient management of metabolic acidosis after cardiac surgery.
How similar studies have gone: Prior work in metabolic acidosis treatment for surgical patients has explored similar agents, supporting investigation into alternative buffering therapies.
Who can join: the full rules
Show full inclusion / exclusion criteria
* Inclusion criteria * Cardiothoracic surgery with use of cardiopulmonary bypass * Presence of metabolic acidosis (defined as a base excess of \<-5) * Minnesota Research Authorization * Exclusion criteria * Non-cardiac surgery patients or cardiac surgery without cardiopulmonary bypass * Absence of metabolic acidosis (metabolic acidosis being defined as a base excess of \<-5) * Pregnant patients * Prisoners * Opt out of Minnesota Research Authorization
Where it's running
-
Mayo Clinic
Rochester, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Misty A. Radosevich, MD — Mayo Clinic
- Study coordinator: Nicole M. Lenort, RRT, LRT
- Email: Lenort.Nicole@mayo.edu
- Phone: 866-265-9263
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.